The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM.
The purpose of this study is to evaluate the efficacy and safety of ofirnoflast in combination with semaglutide in comparison to semaglutide alone in obese participants with T2DM. This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. * The study duration will be up to 28 weeks. * The screening period will be up to 4 weeks * The treatment duration will be 12 weeks. * The follow-up period will be 12 weeks * The visit frequency will be every 4 weeks during the treatment phase of the study. * There will be an anticipated 7 scheduled clinic visits, including 1 screening visit and 2 follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Cleveland Clinic Abu Dhabi
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Assess glycemic control using HbA1c (%)
Evaluate glycemic control using HbA1c (%) from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce HbA1c by at least 1.5%.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess weight loss using body weight measurements
Evaluate weight loss using body weight measurements from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide. This outcome will assess if the participant was able to reduce body weight by at least 5%.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess the change in HbA1c (% point)
Evaluate the change in HbA1c (% point) from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess the change in body composition utilizing DEXA body scan
Evaluate the change in body composition utilizing DEXA body scan from baseline to week 12 in participants treated with ofirnoflast or placebo in combination with semaglutide.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess the PK profile; AUC 0-inf, AUC 0-last, AUC tau, Cmax, tmax, t1/2, and Cl/F
Evaluate the PK profile (AUC 0-inf, AUC 0-last, AUC tau, Cmax, tmax, t1/2, and Cl/F) of ofirnoflast in participants treated with ofirnoflast and semaglutide
Time frame: From first dose through End of Study (up to 12 weeks per participant)
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Assess number of participants who experience Serious Adverse Events (SAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of SAE in participants, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment emergent adverse events (TEAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of TEAE in participants, as assessed according to CTCAE v5.0. The number of participants who experience a TEAEs will be reported.
Time frame: From first dose through End of Study (up to 12 weeks per participant)
Assess number of participants who experience treatment related adverse events (TRAEs)
The safety and tolerability of ofirnoflast or placebo in combination with semaglutide will be evaluated based on the incidence of TRAEs in participants, as assessed according to CTCAE v5.0. The number of participants who experience a TRAEs will be reported.
Time frame: From first dose through End of Study (up to 12 weeks per participant)